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Sponsored by: |
Washington University School of Medicine |
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Information provided by: | Washington University School of Medicine |
ClinicalTrials.gov Identifier: | NCT00869843 |
The primary objectives of this study are:
The secondary objective of the study is to determine a safe (non-popping upper limit) of power per area that will permit a 1 cm depth of tissue destruction without inflow occlusion an da 2 cm depth with inflow occlusion.
Condition | Intervention | Phase |
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Malignant Liver Tumors Liver Metastases From Colorectal Cancer |
Procedure: RF Ablation |
Phase I |
Study Type: | Interventional |
Study Design: | Treatment, Non-Randomized, Open Label, Single Group Assignment, Safety/Efficacy Study |
Official Title: | Phase I Study of Saline Linked Monopolar Surface Radiofrequency (RF) Ablation of Hepatic Tumors |
Enrollment: | 28 |
Study Start Date: | October 2002 |
Study Completion Date: | March 2009 |
Primary Completion Date: | March 2009 (Final data collection date for primary outcome measure) |
Arms | Assigned Interventions |
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Single group | Procedure: RF Ablation |
Treatment Plan: Patients with resectable hepatic metastases confined to the liver and who are referred to the Study Chairs will undergo routine work-up for hepatic resection.
Operative Procedure:
Stage I will be completed and the data analyzed before Stage II commences. Stage I data will be used to define the safe levels for use in Stage II.
Stage I—Depth of coagulation with and without inflow occlusion at fixed times - and powers below the popping threshold.
At surgery, in the absence of extrahepatic disease, the liver will be dissected in the usual fashion for a bi-segmentectomy, hemihepatectomy or larger liver resection. Prior to transection of the liver, saline linked RF ablations will be performed on normal liver tissue within the area of resection away from the tumor and the proposed line of transection.
1 cm and 2 cm diameters will be studied together in 8 patients. They will be treated for a total of 18 minutes (9 min for 1 cm and 9 min for 2 cm with 9 minutes of inflow occlusion. The 4 cm lesions will be studied in 8 other patients, 4 of whom will receive 9 minutes of inflow occlusion.
After resection of the liver and establishment of resection margins on the tumor, the ablated areas of normal liver tissue will be excised frozen and studied for depth of lesion and examined by H & E and histological techniques using vital stains that will allow definition of tissue depth.
Stage II—An ablate and resect Study
Once parameters have been defined on normal liver, the effect of surface RF ablation on resectable hepatic tumors which come to the surface of the liver will be examined. In this portion of the study, tumors will be treated with saline linked RF ablation with a power and a duration of application which has been found to produce the maximum safe depth of coagulation. The surface area of coagulation will be dependent upon the size of the tumor. The area of treatment will encompass the tumor as well as a zone at least 0.5cm outside the edge of the tumor. Inflow occlusion will be used in one half of the patients.
After resection of the liver and establishment of resection margins on the tumor, the ablated areas will be excised frozen and studied for depth of lesion and examined by H & E and histological techniques using vital stains that will allow definition of tissue depth. Twelve tumors will be treated in 12 patients.
Pathology Evaluation
First Group of Patients The normal tissue exposed to RF will be resected, prepared for histo-pathological studies and examined to determine the extent of tissue necrosis and popping, if any.
Second Group of Patients Tumors exposed to RF ablation will be resected and the extent of tissue necrosis and popping will be determined. Also, damage to normal tissue will be examined.
Ages Eligible for Study: | 18 Years and older |
Genders Eligible for Study: | Both |
Accepts Healthy Volunteers: | No |
Eligibility for Stage I (Normal Liver Tissue)
Eligibility for Stage II (Patients with liver metastases from colorectal cancer)
United States, Missouri | |
Washington University School of Medicine | |
St. Louis, Missouri, United States, 63110 |
Principal Investigator: | Steven Strasberg, M.D. | Washington University School of Medicine |
Responsible Party: | Washington University School of Medicine ( Steven Strasberg, MD ) |
Study ID Numbers: | 02-0343 |
Study First Received: | March 25, 2009 |
Last Updated: | March 25, 2009 |
ClinicalTrials.gov Identifier: | NCT00869843 History of Changes |
Health Authority: | United States: Institutional Review Board |
Metastatic colorectal cancer |
Liver Neoplasms Liver Diseases Digestive System Diseases Digestive System Neoplasms Gastrointestinal Diseases Colonic Diseases |
Neoplasm Metastasis Gastrointestinal Neoplasms Intestinal Diseases Rectal Diseases Intestinal Neoplasms Colorectal Neoplasms |
Liver Diseases Digestive System Neoplasms Gastrointestinal Diseases Colonic Diseases Intestinal Diseases Rectal Diseases Intestinal Neoplasms Liver Neoplasms |
Neoplastic Processes Neoplasms Pathologic Processes Neoplasms by Site Digestive System Diseases Neoplasm Metastasis Gastrointestinal Neoplasms Colorectal Neoplasms |